Ephedrine Aguettant 30 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ephedrine Aguettant 30 mg/ml solution for injection

ephedrine, hydrochloride

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Ephedrine Aguettant is and what it is used for
2. What you need to know before using Ephedrine Aguettant
3. How to use Ephedrine Aguettant
4. Possible side effects
5. How to store Ephedrine Aguettant
6. Contents of the pack and other information

1. What Efedrina Aguettant is and what it is used for

This medicine is an injectable solution in ampoule form used for the treatment of low blood pressure during general and local/regional anesthesia, whether spinal or epidural, in adults and adolescents (over 12 years of age).

This product must be used exclusively by the anesthetist or under their supervision.

2. What you need to know before using Efedrina Aguettant

Do not use Efedrina Aguettant if:

• you are allergic to ephedrine hydrochloride or to any of the other ingredients of this medicine (listed in section 6),
• you are taking other indirect sympathomimetic agents such as phenylpropanolamine, phenylephrine, or pseudoephedrine (medicines used to relieve nasal congestion) or methylphenidate (a medicine used to treat “attention deficit hyperactivity disorder (ADHD)”),
• you are taking an alpha-sympathomimetic agent (a medicine used to treat hypotension),
• you are taking or have taken within the last 14 days a non-selective monoamine oxidase inhibitor (a medicine used to treat depression).

Warnings and precautions

Talk to your doctor before starting to use Efedrina Aguettant if:

• you have diabetes;
• you have any cardiovascular disease or other heart problems, including angina (chest pain);
• you have weakness in the blood vessel wall leading to a bulge (aneurysm);
• you have high blood pressure;
• you have stenosis and/or occlusion of blood vessels (occlusive vascular diseases);
• you have an overactive thyroid gland (hyperthyroidism);
• you know or suspect you may have glaucoma (increased eye pressure) or prostate enlargement (prostatic hypertrophy);
• you are about to undergo surgery requiring anesthesia;
• you are currently taking or have taken within the last 14 days any monoamine oxidase inhibitor for the treatment of depression.

Other medicines and Efedrina Aguettant

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.

This information is especially important with the following medicines:

• methylphenidate, used to treat “attention deficit hyperactivity disorder (ADHD)”;
• indirect stimulants of the sympathetic nervous system such as phenylpropanolamine or pseudoephedrine (medicines used as nasal decongestants), or phenylephrine (a medicine used to treat low blood pressure);
• direct stimulators of the alpha receptor of the sympathetic nervous system (oral and/or nasal use) used to treat hypotension (low blood pressure) or nasal congestion, among others;
• medicines used to treat depression;
• ergot alkaloids, a type of medicine used as vasoconstrictors (narrowing of blood vessels) or for dopaminergic action (increasing dopamine activity in the brain);
• linezolid, used to treat infections;
• guanethidine and related medicines, used to treat high blood pressure;
• sibutramine, a medicine used as an appetite suppressant;
• inhaled anesthetics, such as halothane;
• medicines used to treat asthma, such as theophylline;
• corticosteroids, a type of medicine used to reduce inflammation in a wide variety of different diseases;
• medicines for epilepsy;
• doxapram, a medicine used to treat respiratory problems;
• oxytocin, a medicine used during childbirth;
• reserpine and methyldopa and related medicines, used to treat high blood pressure;
• cardiac glycosides, used to treat congestive heart failure and cardiac arrhythmias;
• quinidine, used to treat heart rhythm disorders;
• bicarbonate, used to treat metabolic acidosis or for urine alkalization.

Pregnancy and breastfeeding

Ephedrine should be avoided or used with caution during pregnancy, and only when necessary.

Depending on your condition and following your doctor's recommendations, breastfeeding may need to be interrupted for several days after administration of ephedrine.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor, pharmacist, or nurse before using this medicine.

Interference with diagnostic tests

This medicine contains an active substance that may cause positive results in anti-doping controls.

3. How to use Ephedrine Aguettant

Your doctor or nurse will administer this medicine into a vein (intravenous route). Your doctor will decide what the appropriate dose is and when and how the injection should be given.

Recommended dose:

Adults and elderly patients

You will be given a slow injection of 3 to 6 mg (maximum 9 mg) into a vein, repeated, if necessary, every 3–4 minutes up to a maximum of 30 mg.

The total dose must not exceed 150 mg within a 24-hour period.

This medicine must be diluted before use. For instructions on dilution prior to administration, see the section: "Information intended exclusively for healthcare professionals" at the end of this leaflet.

Use in children and adolescents

• Children under 12 years

This medicine is not recommended for use in children under 12 years of age due to insufficient data on efficacy, safety, and dosage recommendations.

• Children over 12 years

The dosage and method of administration are the same as in adults.

Patients with kidney or liver disease:

No dose adjustment is recommended for patients with kidney or liver disease.

For further information about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The most serious adverse effects requiring immediate medical attention are:

• abnormal heart rhythm;
• palpitations, high blood pressure, rapid heartbeat;
• chest pain, slow heartbeat, low blood pressure;
• heart failure (cardiac arrest);
• cerebral haemorrhage;
• fluid accumulation in the lungs (pulmonary edema);
• increased intraocular pressure (glaucoma);
• difficulty urinating.

Listed below are other adverse effects that may occur while using this medicine.

Frequent (may affect up to 1 in 10 patients):

• confusion, anxiety, depression;
• nervousness, irritability, restlessness, weakness, insomnia, headache, sweating;
• shortness of breath;
• nausea, vomiting.

Frequency not known (cannot be estimated from available data):

• affects blood coagulation;
• allergy;
• changes in personality or in the way you feel or think, fear;
• tremor, excessive salivation;
• decreased appetite;
• reduction in blood potassium levels, changes in blood glucose levels.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ephedrine Aguettant

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the label of the ampoule after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ephedrine Aguettant

• The active substance is ephedrine hydrochloride. Each 1 ml ampoule contains 30 mg of ephedrine hydrochloride.
• The other ingredient is water for injections.

Appearance of the product and contents of the pack

Ephedrine Aguettant 30 mg/ml injectable solution is a clear, colourless liquid. It is supplied in a 1 ml glass ampoule.

This medicine is available in packs of 10 glass ampoules.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Laboratoire Aguettant
1 rue Alexander Fleming
69007 Lyon
France

Manufacturer:

Laboratoire Aguettant
1 rue Alexander Fleming
69007 Lyon
France

Further information on this product is available by contacting the local representative of the Marketing Authorisation Holder:

Local Representative:

Aguettant Ibérica
Baldiri Reixac, 4-8, Torre I, 4º
08028 Barcelona, Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: 08/2024.

Other sources of information

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

Information intended exclusively for healthcare professionals:

Check for clarity and absence of visible particles before infusion.

How to open ampoules with a score mark:

The ampoule is narrowed at the neck. The coloured mark helps to locate the score. Hold the ampoule with the coloured mark facing you.

The ampoule will open easily by placing your thumb on the coloured mark and bending the ampoule downward from top to bottom, as shown in the picture.

Dilution instructions:

Dilute the injectable solution to a final concentration of 3 mg/ml or 5 mg/ml, as appropriate.

This medicine is compatible with 0.9% sodium chloride, lactated Ringer's solution, and 5% glucose.

Overdose

In case of overdose, symptoms such as nausea, vomiting, fever, paranoid psychosis, ventricular and supraventricular arrhythmia, hypertension, respiratory depression, seizures, and coma may occur.

Treatment

A slow intravenous injection of labetalol 50–200 mg with electrocardiographic monitoring may be administered for the treatment of supraventricular tachycardia. Marked hypokalemia (<2.8 mmol·l⁻¹) due to a transcellular shift of potassium predisposes to cardiac arrhythmia and can be corrected with potassium chloride infusion, in addition to propranolol and correction of respiratory alkalosis, if present.

A benzodiazepine and/or a neuroleptic agent may be required to control CNS stimulant effects.

For severe hypertension, parenteral antihypertensive options include intravenous nitrates, calcium channel blockers, sodium nitroprusside, labetalol, or phentolamine.